Reported Oct 14, 2020 · Terminated
Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist…
Medline Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medline Industries Inc · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Kit Model #65193091
- MTO Left Heart Kit - Product UsageNAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM)
- Lot codes and dates
Lot 5619215Exp 06/30/2023
- Amount recalled
- 16 kits
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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